CN105816819A - Method for preparing traditional Chinese medicine composition for treating cerebral thrombosis - Google Patents
Method for preparing traditional Chinese medicine composition for treating cerebral thrombosis Download PDFInfo
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Abstract
The invention discloses a method for preparing a traditional Chinese medicine composition for treating cerebral thrombosis, and belongs to the technical field of traditional Chinese medicine .According to the method, the traditional Chinese medicine composition is prepared by taking leaves of moringa oleifera, radix notoginseng, radix salvia miltiorrhiza, rhizoma chuanxiong, rhizoma sparganii, radix curcumae, spica prunellae, caulis spatholobi, ramulus uncariae cum uncis, fructus viticis, ganoderma lucidum, radix polygoni multiflori, rhizoma arisaematis, medicinal scorpions and licorice roots as raw materials .The traditional Chinese medicine composition prepared through the method has the effects of promoting blood circulation to remove meridian obstruction, dispersing blood stasis to relieve pain, reinforcing qi and nourishing blood and reducing blood glucose, blood lipid and blood pressure and has the advantages of being significant in treatment effect, stable in medicinal efficacy, capable of treating both symptoms and root causes, wide in application range, easy to apply and popularize and the like.
Description
The application is that the application for a patent for invention that applicant Qingdao Lan Shengyang medicine bioengineering science and technology limited Company proposes is (invention entitled: a kind of Chinese medicine composition treating cerebral thrombosis and preparation method thereof, Application No.: 201510481888X, filing date: on August 10th, 2015) divisional application.
Technical field
The invention belongs to technical field of Chinese medicines, a kind of method particularly relating to Chinese medicine composition preparing treatment cerebral thrombosis.
Background technology
Acute cerebrovascular disease is the disease of the hurried cerebral vessels circulatory disturbance of one group of onset, is that neural commonly encountered diseases and frequently-occurring disease, disability rate and fatality rate are the highest.Cerebral thrombosis is one of three big common acute cerebrovascular, Basic disease cause is owing to self pathological changes such as atherosclerosis causes Aldosterone, luminal stenosis inaccessible or forms thrombosis on the basis of narrow, causing brain regional blood flow to reduce or blood supply is interrupted, brain tissue ischemia anoxia causes softening the focal neurological symptom of downright bad appearance.The common site of cerebral thrombosis is internal carotid artery, middle cerebral artery, vertebral artery and basilar artery, thus causes the position of these tremulous pulse blood supplies to form infringement due to hypoxic-ischemic.Clinic mainly shows as occurring suddenly that inclined side upper and lower extremities numbness is unable, facial hemiparalysis, slurred speech etc., along with advancing of disease, the complication such as pulmonary infection, cerebrocardiac syndrome, injury of hypothalamus, syndrome of inapropriate ADH and multiple organ failure, MOF time serious, can be produced.
Western medical treatment cerebral thrombosis, with the blood circulation improving Cerebral Region as early as possible, promotes neurological functional recovery as principle, and conventional Therapeutic Method has Hemodilution Therapy, thrombolytic therapy and anticoagulant therapy.Thrombolytic therapy is applicable to the extreme early of cerebral thrombosis, needs to treat in 3-6 hour in morbidity, treats in time within this time period, and effect is notable, but exceedes this time period and reapply thrombolytic therapy, and effect is the lowest.Hemodilution Therapy and anticoagulant therapy are mainly carried out by intravenous drip relative medicine, and Therapeutic Method is inconvenient.Western medicine therapy side effect is obvious, expensive, and the treatment later stage also needs prolonged administration of drugs maintaining treatment effect, prevention of recurrence.
Cerebral thrombosis belongs to TCM Stroke category, is referred to as ancient times such as apoplexy, coma, hemiplegia, hemiplegia, apoplexy etc..According to the dialectical principle treated, cerebral thrombosis can be divided into again the cards such as wind sun resistance network, obstruction of collateral caused by windphlegm, phlegm-heat accumulation, blood stasis due to qi deficiency, deficiency of kidney essence.Cow-bezoar bolus for resurrection and restorative bolus are the medicines that current Chinese traditional treatment apoplexy is relatively common, have certain curative effect for treatment cerebral thrombosis, but price is sufficiently expensive.
Chinese patent application 201410113186.1 discloses a kind of Chinese medicine composition treating cerebral thrombosis and preparation method thereof, and it is mainly prepared by following raw material: Semen Persicae 10-50 part, Rhizoma Et Radix Notopterygii 10-20 part, Flos Sophorae 5-20 part, Radix Cynanchi Paniculati 5-15 part, Radix Rehmanniae Preparata 5-10 part, Bulbus Lilii 5-15 part, Flos Lonicerae 5-15 part, Radix Salviae Miltiorrhizae 1-10 part, Fructus Lycii 5-15 part, Poria 9-15 part, Rhizoma Chuanxiong 9-15 part, Radix Angelicae Dahuricae 5-15 part, berberine 0.2-9 part, Radix Paeoniae Alba 5.5-15 part, Radix Rhodiolae 6-9 part, Radix Glycyrrhizae 10-15 part.This Chinese medicine composition has the function of blood circulation promoting and blood stasis dispelling, anti-inflammatory and antalgic, but it is reducing blood glucose, blood fat and blood pressure, and the function of the aspects such as prevention cerebral thrombosis is the most notable.
The features such as Chinese traditional treatment cerebral thrombosis, has low side effect, treating both the principal and secondary aspects of a disease, have a extensive future, and seek a kind of rapid-action, good effect, efficacy stability, and the medicine of the treatment cerebral thrombosis of low cost and use easy to spread is this area urgent problem.
Summary of the invention
The technical problem to be solved in the present invention is to provide a kind of method of Chinese medicine composition preparing treatment cerebral thrombosis, the Chinese medicine composition that the method prepares has promoting blood circulation to remove obstruction in the collateral, eliminating stasis to stop pain, benefiting QI and nourishing blood and reduce blood glucose, blood fat and effect of blood pressure, possess that therapeutic effect is notable, efficacy stability, treating both the principal and secondary aspects of a disease, the advantage such as applied widely and application easy to spread.
Chinese medicine composition of the present invention is prepared from by the raw material of following parts by weight:
Leaf of Moringa 28-36 part, Radix Notoginseng 23-28 part, Radix Salviae Miltiorrhizae 20-25 part, Rhizoma Chuanxiong 13-18 part, Rhizoma Sparganii 13-17 part, Radix Curcumae 12-17 part, Spica Prunellae 15-20 part, Caulis Spatholobi 15-19 part, Ramulus Uncariae Cum Uncis 8-12 part, Fructus Viticis 6-14 part, Ganoderma 7-11 part, Radix Polygoni Multiflori 5-8 part, Rhizoma Arisaematis 3-7 part, Scorpio 3-9 part and Radix Glycyrrhizae 5-13 part.
Preferably, described Chinese medicine composition is prepared from by the raw material of following parts by weight:
Leaf of Moringa 34 parts, Radix Notoginseng 26 parts, Radix Salviae Miltiorrhizae 22 parts, Rhizoma Chuanxiong 15 parts, Rhizoma Sparganii 16 parts, Radix Curcumae 15 parts, Spica Prunellae 18 parts, Caulis Spatholobi 18 parts, Ramulus Uncariae Cum Uncis 10 parts, Fructus Viticis 12 parts, Ganoderma 9 parts, Radix Polygoni Multiflori 7 parts, Rhizoma Arisaematis 5 parts, Scorpio 6 parts and 9 parts of Radix Glycyrrhizae.
Preferably, described Chinese medicine composition is prepared from by the raw material of following parts by weight:
Leaf of Moringa 28 parts, Radix Notoginseng 23 parts, Radix Salviae Miltiorrhizae 20 parts, Rhizoma Chuanxiong 13 parts, Rhizoma Sparganii 13 parts, Radix Curcumae 12 parts, Spica Prunellae 15 parts, Caulis Spatholobi 15 parts, Ramulus Uncariae Cum Uncis 8 parts, Fructus Viticis 6 parts, Ganoderma 7 parts, Radix Polygoni Multiflori 5 parts, Rhizoma Arisaematis 3 parts, Scorpio 3 parts and 5 parts of Radix Glycyrrhizae.
Preferably, described Chinese medicine composition is prepared from by the raw material of following parts by weight:
Leaf of Moringa 36 parts, Radix Notoginseng 28 parts, Radix Salviae Miltiorrhizae 25 parts, Rhizoma Chuanxiong 18 parts, Rhizoma Sparganii 17 parts, Radix Curcumae 17 parts, Spica Prunellae 20 parts, Caulis Spatholobi 19 parts, Ramulus Uncariae Cum Uncis 12 parts, Fructus Viticis 14 parts, Ganoderma 11 parts, Radix Polygoni Multiflori 8 parts, Rhizoma Arisaematis 7 parts, Scorpio 9 parts and 13 parts of Radix Glycyrrhizae.
The method of a kind of Chinese medicine composition preparing treatment cerebral thrombosis of the present invention, comprises the following steps:
(1) raw material is weighed: leaf of Moringa 28-36 part, Radix Notoginseng 23-28 part, Radix Salviae Miltiorrhizae 20-25 part, Rhizoma Chuanxiong 13-18 part, Rhizoma Sparganii 13-17 part, Radix Curcumae 12-17 part, Spica Prunellae 15-20 part, Caulis Spatholobi 15-19 part, Ramulus Uncariae Cum Uncis 8-12 part, Fructus Viticis 6-14 part, Ganoderma 7-11 part, Radix Polygoni Multiflori 5-8 part, Rhizoma Arisaematis 3-7 part, Scorpio 3-9 part and Radix Glycyrrhizae 5-13 part, standby；
(2) moringa oleifera leaf extractive is prepared: take dry leaf of Moringa, 200-270 mesh sieve is crossed after pulverizing, adding the ethanol solution that concentration expressed in percentage by volume is 60%-80%, reflux, extract, 2-3 time according to 12-15 times of leaf of Moringa fine powder gross weight, each return time is 2-3h, united extraction liquid, reclaiming ethanol, being evaporated to relative density under 60-65 DEG C of environment is the extractum of 1.20-1.25, is spray-dried, cross 80-100 mesh sieve, obtain moringa oleifera leaf extractive；
(3) take Radix Salviae Miltiorrhizae, Rhizoma Sparganii, Radix Curcumae, Spica Prunellae, Caulis Spatholobi, Fructus Viticis, Radix Polygoni Multiflori, Scorpio, Rhizoma Arisaematis and Radix Glycyrrhizae, pulverize, add the soak by water 3-4h of medical material gross weight 6-8 times amount, filter；Filtering residue adds the soak by water 2.5-2h of medical material gross weight 4-6 times amount, filters；Merging twice filtrate, being evaporated to relative density under 60-65 DEG C of environment is the extractum of 1.20-1.25, drying under reduced pressure, crosses 80-100 mesh sieve, obtain extractum fine powder after pulverizing；
(4) take Radix Notoginseng, Rhizoma Chuanxiong, Ramulus Uncariae Cum Uncis and Ganoderma, grind, cross 80-100 mesh sieve, fully mix with above-mentioned moringa oleifera leaf extractive, extractum fine powder, obtain this Chinese medicine composition.
Utilizing modern general Chinese medicine preparation technology, Chinese medicine composition of the present invention can be made into the finished product preparation of clinical needs, such as dosage forms such as granule, pill, powder, tablet or capsules.
The source of Chinese crude drug, nature and flavor used by Chinese medicine composition of the present invention, return through and effect:
Leaf of Moringa: this product is the dried leaves of Moringaceae plant Moringa.Bitter in the mouth, slightly warm in nature；Leaf of Moringa has the effects such as blood sugar lowering, blood fat reducing, blood pressure lowering, antitumor, antioxidation and enhancing immunity.
Radix Notoginseng: this product is the dry root of panax araliaceae plant.Sweet in the mouth, micro-hardship, warm in nature；Return liver, stomach warp；Dissipating blood stasis stops blooding, subduing swelling and relieving pain.
Radix Salviae Miltiorrhizae: this product is the dry root and rhizome of labiate Radix Salviae Miltiorrhizae.Bitter in the mouth, cold nature；GUIXIN, Liver Channel；Stasis-dispelling and pain-killing, promoting blood circulation to restore menstrual flow, clear away heart-fire relieving restlessness.
Rhizoma Chuanxiong: this product is the dry rhizome of samphire Rhizoma Chuanxiong.Acrid in the mouth, warm in nature；Return liver, gallbladder, pericardium channel；Blood-activating and qi-promoting, wind-expelling pain-stopping.
Rhizoma Sparganii: this product is the dry tuber of Sparganiaceae plant rhizoma scirpi.Acrid in the mouth, hardship, property is put down；Return liver, spleen channel；Removing blood stasis circulation of qi promoting, removing food stagnancy pain relieving.
Caulis Spatholobi: this product is the dry rattan of leguminous plant spatholobus suberectus (Caulis Sargentodoxae, Radix seu Caulis Verntilaginis Leiocarpae, SANYE Caulis Spatholobi, nine layers of wind).Bitter in the mouth, sweet, warm in nature；Return liver, kidney channel；Enrich blood, invigorate blood circulation, dredging collateral.
Spica Prunellae: this product is the dry fruit ear of labiate Spica Prunellae.Acrid in the mouth, hardship, cold in nature；Return liver, gallbladder meridian；Relieve inflammation or internal heat, improving eyesight, eliminating stagnation, detumescence.
Radix Curcumae: this product is the dried root of zingiberaceous plant RADIX CURCUMAE, Rhizoma Curcumae Longae, Guangxi zedoary or Rhizoma Curcumae.Acrid in the mouth, hardship, cold in nature；Return liver, the heart, lung meridian；Promoting QI circulation for relieving depression, removing heat from blood removing blood stasis with potent drugs, promoting the function of the gallbladder to alleviate jaundice.
Ramulus Uncariae Cum Uncis: this product is Maguireothamnus speciosus Ramulus Uncariae Cum Uncis, Ramulus Uncariae macrophyllae, Ramulus Uncariae Cum Uncis, Uncaria sinensis (Oliv.) Havil. or the dry stem and branch with belt hook of stockless fruit Ramulus Uncariae Cum Uncis.Sweet in the mouth, cool in nature；Return liver, pericardium channel；Heat clearing away suppressing the hyperactive liver, dispelling wind and relieving convulsion.
Fructus Viticis: this product is the dry mature fruit of Verbenaceae Vitex rotundifolia or wild pepper.Acrid in the mouth, hardship, cold nature；Return bladder, liver, stomach warp；Dispelling wind and heat pathogens, the clear profit head.
Ganoderma: this product is the dry sporophore of On Polyporaceae Ganoderma lucidum (Leyss. Ex Fr.) Karst. or Ganoderma.Sweet in the mouth, property is put down；GUIXIN, lung, liver, kidney channel；Replenishing QI and blood, tranquilizing mind, strengthening the spleen and stomach.
Radix Polygoni Multiflori: this product is the dried root of polygonum multiflorum thunb.Bitter in the mouth, sweet, puckery, warm in nature；Return liver, the heart, kidney channel；Tonifying liver, kidney tonifying, nourishes blood, dispels the wind.
Rhizoma Arisaematis: this product is the dry tuber of aroid Rhizoma Arisaematis, Arisaema heterophyllum B1. or arisaema amurense Maxim.Bitter in the mouth, pungent, warm in nature；Return lung, liver, spleen channel；Drying dampness to eliminate phlegm, expellings wind and relieving convulsion, mass dissipating and swelling eliminating.
Scorpio: this product is the dry body of Buthidae animal Scorpio.Acrid in the mouth, property is put down；Return Liver Channel；Endogenous wind stopping spasmolytic, dispersing pathogen accumulation, removing obstruction in the collateral to relieve pain.
Radix Glycyrrhizae: this product is the dry root of glycyrrhizic legume, Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L..Sweet in the mouth, property is put down；GUIXIN, lung, spleen, stomach warp；Invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription.
The prescription analysis of medicament composing prescription of the present invention:
Medicament composing prescription of the present invention with leaf of Moringa, Radix Notoginseng and Radix Salviae Miltiorrhizae as monarch drug, promoting blood circulation to remove blood stasis, subduing swelling and relieving pain, blood sugar lowering, blood fat and blood pressure；With Rhizoma Chuanxiong, Rhizoma Sparganii, Radix Curcumae, Spica Prunellae and Caulis Spatholobi as ministerial drug, blood-activating and qi-promoting, removing food stagnancy pain relieving, resolving mass and removing the obstruction of the collateral, nourishes blood and enriches blood；With Ramulus Uncariae Cum Uncis, Fructus Viticis, Ganoderma, Radix Polygoni Multiflori, Rhizoma Arisaematis and Scorpio as adjuvant drug, the clear profit head, the liver and the kidney tonifying, nourishing blood and invigorating qi；With Radix Glycyrrhizae for making medicine, invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, coordinating the actions of various ingredients in a prescription, make all medicines arrange in pairs or groups, synergism, jointly reach effect of promoting blood circulation to remove obstruction in the collateral, eliminating stasis to stop pain, benefiting QI and nourishing blood, blood fat reducing, blood sugar lowering and blood pressure lowering, cerebral thrombosis is had the most significantly treatment and prevention effect.
Compared with prior art, the present invention has a following technical advantage:
(1) preparation method of the present invention is easy, easy to operate, is suitable for modern pharmaceutical process lot, the feature quickly produced.
(2) Chinese medicine composition prepared by the present invention has rapid-action in terms for the treatment of cerebral thrombosis, good effects etc. significantly treat advantage, simultaneously, Chinese medicine composition of the present invention can substantially reduce blood glucose, blood fat and blood pressure level, arteriosclerosis and thrombosis also there are is certain inhibitory action, there is the effect significantly preventing cerebral thrombosis.
(3) Chinese medicine composition prepared by the present invention has promoting blood circulation to remove obstruction in the collateral, eliminating stasis to stop pain and benefiting QI and nourishing blood effect, also has efficacy stability, rapid-action, toxic and side effects is low and the advantage such as application easy to spread simultaneously.
Detailed description of the invention
Hereinafter will further describe the present invention by specific embodiment, the present invention is not limited only to following example.Within the scope of the invention or without departing from present disclosure, spirit and scope, change that the present invention is carried out, combine or replace, will be apparent to the person skilled in the art, be included within the scope of the present invention.
Embodiment 1
The embodiment of the present invention 1 Chinese medicine composition is mainly prepared from by the raw material of following parts by weight:
Leaf of Moringa 28 parts, Radix Notoginseng 23 parts, Radix Salviae Miltiorrhizae 20 parts, Rhizoma Chuanxiong 13 parts, Rhizoma Sparganii 13 parts, Radix Curcumae 12 parts, Spica Prunellae 15 parts, Caulis Spatholobi 15 parts, Ramulus Uncariae Cum Uncis 8 parts, Fructus Viticis 6 parts, Ganoderma 7 parts, Radix Polygoni Multiflori 5 parts, Rhizoma Arisaematis 3 parts, Scorpio 3 parts and 5 parts of Radix Glycyrrhizae.
Preparation method is as follows:
(1) moringa oleifera leaf extractive is prepared: take dry leaf of Moringa, 250 mesh sieves are crossed after pulverizing, it is the ethanol solution of 70% according to 15 times of addition concentration expressed in percentage by volumes of leaf of Moringa fine powder gross weight, reflux, extract, 2 times, each return time is 3h, united extraction liquid, reclaim ethanol, be evaporated to the extractum of relative density 1.25 under 60 DEG C of environment, be spray-dried, cross 100 mesh sieves, obtain moringa oleifera leaf extractive；
(2) take Radix Salviae Miltiorrhizae, Rhizoma Sparganii, Radix Curcumae, Spica Prunellae, Caulis Spatholobi, Fructus Viticis, Radix Polygoni Multiflori, Scorpio, Rhizoma Arisaematis and Radix Glycyrrhizae, pulverize, add the soak by water 4h of medical material gross weight 7 times amount, filter；Filtering residue adds the soak by water 2.5h of medical material gross weight 5 times amount, filters；Merging twice filtrate, being evaporated to relative density under 60 DEG C of environment is the extractum of 1.25, drying under reduced pressure, crosses 100 mesh sieves, obtain extractum fine powder after pulverizing；
(3) take Radix Notoginseng, Rhizoma Chuanxiong, Ramulus Uncariae Cum Uncis and Ganoderma, grind, cross 100 mesh sieves, fully mix with above-mentioned moringa oleifera leaf extractive, extractum fine powder, obtain this Chinese medicine composition.
Embodiment 2
The embodiment of the present invention 2 Chinese medicine composition is mainly prepared from by the raw material of following parts by weight:
Leaf of Moringa 36 parts, Radix Notoginseng 28 parts, Radix Salviae Miltiorrhizae 25 parts, Rhizoma Chuanxiong 18 parts, Rhizoma Sparganii 17 parts, Radix Curcumae 17 parts, Spica Prunellae 20 parts, Caulis Spatholobi 19 parts, Ramulus Uncariae Cum Uncis 12 parts, Fructus Viticis 14 parts, Ganoderma 11 parts, Radix Polygoni Multiflori 8 parts, Rhizoma Arisaematis 7 parts, Scorpio 9 parts and 13 parts of Radix Glycyrrhizae.
Preparation method is with embodiment 1.
Embodiment 3
The embodiment of the present invention 3 Chinese medicine composition is mainly prepared from by the raw material of following parts by weight:
Leaf of Moringa 34 parts, Radix Notoginseng 26 parts, Radix Salviae Miltiorrhizae 22 parts, Rhizoma Chuanxiong 15 parts, Rhizoma Sparganii 16 parts, Radix Curcumae 15 parts, Spica Prunellae 18 parts, Caulis Spatholobi 18 parts, Ramulus Uncariae Cum Uncis 10 parts, Fructus Viticis 12 parts, Ganoderma 9 parts, Radix Polygoni Multiflori 7 parts, Rhizoma Arisaematis 5 parts, Scorpio 6 parts and 9 parts of Radix Glycyrrhizae.
Preparation method is with embodiment 1.
Embodiment 4
The embodiment of the present invention 4 Chinese medicine composition is mainly prepared from by the raw material of following parts by weight:
Leaf of Moringa 30 parts, Radix Notoginseng 26 parts, Radix Salviae Miltiorrhizae 22 parts, Rhizoma Chuanxiong 13 parts, Rhizoma Sparganii 17 parts, Radix Curcumae 16 parts, Spica Prunellae 15 parts, Caulis Spatholobi 16 parts, Ramulus Uncariae Cum Uncis 11 parts, Fructus Viticis 10 parts, Ganoderma 8 parts, Radix Polygoni Multiflori 7 parts, Rhizoma Arisaematis 6 parts, Scorpio 4 parts and 13 parts of Radix Glycyrrhizae.
Preparation method is with embodiment 1.
Chinese medicine composition pharmacodynamic study of the present invention:
Test one: the Chinese medicine composition of the present invention impact on blood stasis model hemorheology of rat
1, experimental animal: regular grade SD rat 90, body weight 260-320g, male and female half and half, is randomly divided into 9 groups, often group 10.
2, trial drug and dosage regimen:
A group: the Chinese medicine composition embodiment of the present invention 1 prepared, is deployed into, with water, the suspension that concentration is 0.6g/ml, 0.4g/ml and 0.2g/ml, standby.Take 3 groups of rats, it is labeled as A group high dose group (dosage 2.4g/kg), middle dosage group (dosage 1.6g/kg) and low dose group (dosage 0.8g/kg), high dose group concentration is the drug suspension of 0.6g/ml, middle dosage group concentration is the drug suspension of 0.4g/ml, low dose group concentration is the drug suspension of 0.2g/ml, according to dosage gavage every day 1 time, successive administration 7 days.
B group: trial drug is the Chinese medicine composition that the embodiment of the present invention 2 prepares, and dosage regimen is with A group.
Positive controls: positive control drug is Xueshuan xinmaining Tablet (traditional Chinese medicines quasi-word Z20030145, Jilin Huakang Pharmaceutical Co., Ltd), it is deployed into the suspension of 0.6g/ml with water, takes 1 group of rat, by dosage gastric infusion every day 1 time of 2.4g/kg, successive administration 7 days.
Model control group: take 1 group of rat, isometric(al) normal saline gavage every day 1 time, continuous gavage 7 days.
Normal group: take 1 group of rat, the same model control group of dosage regimen.
3, the foundation of rat blood stasis models:
After last is administered 1h, in addition to Normal group, remaining respectively organizes rat skin lower injection adrenalin hydrochloride 10 μ g/kg totally 2 times, is spaced 4h.Between double injection adrenalin hydrochloride, each every 2h front and back, rat is immersed 5min in the frozen water that water temperature is 4 DEG C, causes blood stasis model.After modeling, water is can't help in the equal fasting of rat of each group, and the next morning anaesthetizes with pentobarbital sodium, heart extracting blood 4ml, wherein 2ml shakes up standing in injecting rapidly the anticoagulant tube containing heparin, after measuring whole blood viscosity, by its low-speed centrifugal, isolate blood plasma, measure plasma viscosity and hematocrit (Hct)；In additionally 2ml injects the silication pipe containing 3.8% sodium citrate, it is used for detecting erythrocyte sedimentation rate (ESR), finally calculates ESR equation K value.
4, result of the test: as shown in table 1.
The impact on blood stasis model hemorheology of rat of table 1 Chinese medicine composition of the present invention
The impact on blood stasis model hemorheology of rat of continued 1 Chinese medicine composition of the present invention
Note: compare with Normal group, model control group#P ＞ 0.05,##P ＞ 0.01；Compare with model control group, drug test group*P ＜ 0.05,**P ＜ 0.01.
5, conclusion (of pressure testing):
Test data shows, compares with Normal group, and the equal significance of hemorheology index of rat blood stasis models group increases, consistent with the hemorheology feature of blood stasis type disease, can be used for studying the Chinese medicine composition of the present invention therapeutic effect to cerebral thrombosis.
Compare with model control group, Chinese medicine composition A group of the present invention, the Chinese medicine composition high dose group that i.e. embodiment of the present invention 1 prepares and middle dosage group all can significantly improve the hemorheology index of blood stasis model rat, action effect is better than positive controls, and low dose group also can reduce the level of each hemorheology index to a certain extent.
Compare with model control group, Chinese medicine composition B group of the present invention, the Chinese medicine composition high dose group that i.e. embodiment of the present invention 2 prepares can significantly reduce the hemorheology index level of rat, effect is better than positive controls, and middle dosage group and low dose group also have certain reducing effect to hemorheology index level.
To sum up, Chinese medicine composition of the present invention is notable to the therapeutic effect of blood stasis, can be used for the clinical treatment of cerebral thrombosis.
Test two: Chinese medicine composition of the present invention is on cerebral thrombosis rat model plasma lysophosphatidic acid and the impact of phosphatidic acid level
1, test principle and purpose: lysophosphatidic acid (LPA) and phosphatidic acid (PA) are all the intermediate products of phospholipid metabolism.Under normal circumstances, LPA content in blood plasma is the lowest, and the platelet of human or animal can make LPA level in blood plasma raise by the effect release LPA of phospholipase after being activated by stimulated by thrombin.LPA can assemble and smooth muscle contraction by stimulating platelet, promotes blood vessel endothelium hypertrophy, plays an important role in blood coagulation and thrombosis.PA is the early stage releaser of a kind of cerebral ischemia, in the 24h of ischemia produce, its level increase the degree reflecting cerebral hypoxia ischemia, the excessive formation with oxygen-derived free radicals is relevant.This test proves its preventive effect to cerebral thrombosis by studying Chinese medicine composition of the present invention to the impact of LPA and PA level in cerebral thrombosis rat model blood plasma.
2, the foundation of cerebral thrombosis in rats model:
By rat with after 1% pentobarbital sodium (dosage 30-40mg/kg) intraperitoneal injection of anesthesia, dorsal position is fixed on operating-table.The longitudinally slit skin in the positive middle part of neck, otch is about 2cm, separates musculi colli, right carotid of dissociating, upwards separates external carotid artery and internal carotid artery from common carotid artery crotch.Ligation external carotid artery, then to basis cranii direction separation internal carotid artery, isolates arteria pterygopalatina at basis cranii, and ligatures its root, only retains internal carotid artery and enters basis cranii trunk.Ligation common carotid artery, 2 micro-arterial clamps of temporary folder that keeps at a certain distance away closes internal carotid artery, an osculum is cut with eye scissors at common carotid artery below proximal part vascular clamp, taken out in insertion the conduit of Thrombus inducer thrombin 10U and normal saline 0.01ml fixing after, remove proximal part vascular clamp, a small amount of blood inflow catheter head end, place about 10min and form a microthrombus, then another vascular clamp is removed, slowly this thrombosis and thrombin are injected internal carotid artery, extract conduit, and common carotid artery incision is ligatured, sewing up the incision, postoperative single cage is raised.
Sham operated rats operative process ibid, injects normal saline rather than Thromboembolus and thrombin.
3, test packet and dosage regimen:
Regular grade SD rat 60, body weight 280 ~ 350g, male and female half and half, it is randomly divided into 6 groups, often group 10.
Model control group: take 1 group of rat, isometric(al) normal saline gavage every day 1 time, continuous gavage 7 days.
Drug test group: the Chinese medicine composition embodiment of the present invention 3 prepared, is deployed into, with water, the suspension that concentration is 0.6g/ml, 0.4g/ml and 0.2g/ml, standby.Take 3 groups of rats, it is labeled as drug test group high dose group (dosage 2.4g/kg), middle dosage group (dosage 1.6g/kg) and low dose group (dosage 0.8g/kg), high dose group concentration is the drug suspension of 0.6g/ml, middle dosage group concentration is the drug suspension of 0.4g/ml, low dose group concentration is the drug suspension of 0.2g/ml, according to dosage gavage every day 1 time, successive administration 7 days.
Positive controls: positive control drug is Xueshuan xinmaining Tablet (traditional Chinese medicines quasi-word Z20030145, Jilin Huakang Pharmaceutical Co., Ltd), is deployed into the suspension of 60% with water, takes 1 group of rat, by dosage gastric infusion every day 1 time of 2.4g/kg, successive administration 7 days.
Sham operated rats: take 1 group of rat, isometric(al) normal saline gavage every day 1 time, continuous gavage 7 days.
Normal group: take 1 group of rat, isometric(al) normal saline gavage every day 1 time, continuous gavage 7 days.
4, test method:
Model control group: prohibiting diet 12h after last gavage, the method for building up with reference to above-mentioned cerebral thrombosis in rats model sets up model.Postoperative 3h, by 1% pentobarbital sodium (dosage 30-40mg/kg) intraperitoneal injection of anesthesia, the level of LPA and PA in abdominal aortic blood 4ml, detection blood plasma.
Drug test group: the same model control group of test method.
Positive controls: the same model control group of test method.
Sham operated rats: prohibit diet 12h after last gavage, carry out sham-operation.Postoperative 3h, by 1% pentobarbital sodium (dosage 30-40mg/kg) intraperitoneal injection of anesthesia, the level of LPA and PA in abdominal aortic blood 4ml, detection blood plasma.
Normal group: prohibit diet 12h after last gavage, by 1% pentobarbital sodium (dosage 30-40mg/kg) intraperitoneal injection of anesthesia, the level of LPA and PA in abdominal aortic blood 4ml, detection blood plasma.
5, result of the test: as shown in table 2.
Table 2 is respectively organized rat plasma LPA, PA level and is compared
Note: compare with model control group, positive controls and drug test group*P ＜ 0.05,**P ＜ 0.01；Compare with Normal group, sham operated rats and model control group▲▲P ＞ 0.01.
6, conclusion (of pressure testing):
Test data shows, compared with Normal group, LPA and the PA level of rats in sham-operated group is without significant change, and LPA and the PA water mean pole of model control group rat significantly raises (P ＞ 0.01).
Comparing with model control group, after the Chinese medicine composition of the present invention of dosage high, middle is intervened in advance, the rising trend of rat LPA and PA level is significantly suppressed, and effect is better than positive controls.And low dose group also has the effect that certain suppression LPA, PA level raises, effect is suitable with positive controls.
To sum up, Chinese medicine composition of the present invention has the effect that suppression LPA and PA level raises, and has significant preventive effect for thrombosis and cerebral ischemia.
Test three: the clinical trial of Chinese medicine composition of the present invention
(1) case and diagnostic criteria
1, diagnostic criteria:
With reference to Chinese Medical Association about cerebral thrombosis and the diagnostic criteria of cerebral embolism:
1) often fall ill under rest state；
2) most of nothings are substantially had a headache and vomit；
3) morbidity can be relatively slow, is the most gradually in progress, or carries out in stage, the most relevant with cerebral atherosclerosis, it is possible to see arteritis, hematopathy etc.；
4) Clear consciousness or slight obstacle in 1～2 day after general morbidity；
5) there are Internal Carotid System and (or) Vertebro-basilar System sings and symptoms；
6) Lumbar puncture CSF the most should not contain blood；
7) CT examination finds cerebral location of lesions.
Meet above diagnostic criteria patient and informed consent, be ready that experimenter all can inclusive criteria.
2, get rid of and reject case standard:
1) transient ischemic attack；
2) check that confirmation is merged atrial fibrillation caused cerebral embolism by the cerebral tumor, cerebral trauma, cerebral parasitosis, dysbolismus, rheumatic heart disease, coronary heart disease, other heart disease；
3) gestation or women breast-feeding their children, to this medicine composition allergy sufferers；
4) the severe primary diseases such as liver, kidney, hemopoietic system and hormonal system, psychotic it are associated with；
5) do not meet inclusive criteria, not by regulation medication, cannot judge that curative effect or data affect the treatment or safety judgement person the most entirely.
(2) clinical trial protocol
1, physical data:
Go out 160 examples by diagnosis standard screening and meet the clinical volunteers patient of diagnosis of cerebral thrombosis standard, be randomly divided into treatment group and matched group two groups, often organize each 80 examples, 42 ~ 69 years old age, 56.5 years old mean age.The influence factors such as two groups of ages, state of an illness distributions, through statistical procedures, there was no significant difference, meet packet condition.
2, trial drug and test method:
Treatment group: the Chinese medicine composition fill capsule of the present invention embodiment of the present invention 3 prepared, every seed lac capsule drug containing 0.55g, each takes 2, three times a day.
Matched group: take Xueshuan xinmaining Tablet (traditional Chinese medicines quasi-word Z20030145, Jilin Huakang Pharmaceutical Co., Ltd), each take 2, three times a day.
Two groups was all 1 course for the treatment of with 4 weeks, evaluated curative effect, and the lipid-lowering effect of the trade-off medicine by treatment Patients Before And After blood lipids index after 3 courses for the treatment of.
3, curative effect determinate standard:
Judge according to " the Chinese medical disease Standardization of diagnosis and curative effect " that State Administration of Traditional Chinese Medicine formulates:
Cure: symptom and sign disappear, and substantially can live on one's own life；
Take a turn for the better: symptom and sign improvement, energy cane action, or basic living can be taken care of oneself；
Do not heal: symptom and sign are unchanged.
4, therapeutic effect:
1) two groups of patient clinical comparitive study, as shown in table 3.
Table 3 therapeutic effect
Clinical data shows, Chinese medicine composition of the present invention reaches 70% for the treatment cure rate of cerebral thrombosis, and total effective rate reaches 93.75%, all far above matched group, it was demonstrated that traditional Chinese medicine composition for treating effect of the present invention is notable.
2) two groups of patients with lipid's Indexes Comparison, as shown in table 4.
Blood lipids index before and after table 4 patient treatment
Note: compare with before treatment, * P ＜ 0.05 after treatment；* P ＜ 0.01.
Clinical testing data shows, traditional Chinese medicine composition for treating cerebral thrombosis of the present invention can substantially lower blood lipid, has the function of significant regulating lipid metabolism, and blood fat reducing ability is substantially better than matched group.
5, conclusion (of pressure testing):
This clinical trial uses the prescription drugs Xueshuan xinmaining Tablet for the treatment of cerebral thrombosis the most conventional as a control group, by comparing with the therapeutic effect of Chinese medicine composition of the present invention, highlights the curative effect of Chinese medicine composition of the present invention.Clinical testing data shows, Chinese medicine composition of the present invention is notable for the therapeutic effect of cerebral thrombosis, and has obvious lipid-reducing function, can be as cerebral thrombosis treatment drug use, and clinical generalization value is high.
Claims (5)
1. the method for the Chinese medicine composition preparing treatment cerebral thrombosis, it is characterised in that comprise the following steps:
(1) raw material is weighed: leaf of Moringa 28-36 part, Radix Notoginseng 23-28 part, Radix Salviae Miltiorrhizae 20-25 part, Rhizoma Chuanxiong 13-18 part, Rhizoma Sparganii 13-17 part, Radix Curcumae 12-17 part, Spica Prunellae 15-20 part, Caulis Spatholobi 15-19 part, Ramulus Uncariae Cum Uncis 8-12 part, Fructus Viticis 6-14 part, Ganoderma 7-11 part, Radix Polygoni Multiflori 5-8 part, Rhizoma Arisaematis 3-7 part, Scorpio 3-9 part and Radix Glycyrrhizae 5-13 part, standby；
(2) moringa oleifera leaf extractive is prepared: take dry leaf of Moringa, 200-270 mesh sieve is crossed after pulverizing, adding the ethanol solution that concentration expressed in percentage by volume is 60%-80%, reflux, extract, 2-3 time according to 12-15 times of leaf of Moringa fine powder gross weight, each return time is 2-3h, united extraction liquid, reclaiming ethanol, being evaporated to relative density under 60-65 DEG C of environment is the extractum of 1.20-1.25, is spray-dried, cross 80-100 mesh sieve, obtain moringa oleifera leaf extractive；
(3) take Radix Salviae Miltiorrhizae, Rhizoma Sparganii, Radix Curcumae, Spica Prunellae, Caulis Spatholobi, Fructus Viticis, Radix Polygoni Multiflori, Scorpio, Rhizoma Arisaematis and Radix Glycyrrhizae, pulverize, add the soak by water 3-4h of medical material gross weight 6-8 times amount, filter；Filtering residue adds the soak by water 2.5-2h of medical material gross weight 4-6 times amount, filters；Merging twice filtrate, being evaporated to relative density under 60-65 DEG C of environment is the extractum of 1.20-1.25, drying under reduced pressure, crosses 80-100 mesh sieve, obtain extractum fine powder after pulverizing；
(4) take Radix Notoginseng, Rhizoma Chuanxiong, Ramulus Uncariae Cum Uncis and Ganoderma, grind, cross 80-100 mesh sieve, fully mix with above-mentioned moringa oleifera leaf extractive, extractum fine powder, obtain this Chinese medicine composition.
2. the method for the Chinese medicine composition of preparation treatment cerebral thrombosis as claimed in claim 1, it is characterized in that, the parts by weight of the raw material of described Chinese medicine composition are as follows: leaf of Moringa 34 parts, Radix Notoginseng 26 parts, Radix Salviae Miltiorrhizae 22 parts, Rhizoma Chuanxiong 15 parts, Rhizoma Sparganii 16 parts, Radix Curcumae 15 parts, Spica Prunellae 18 parts, Caulis Spatholobi 18 parts, Ramulus Uncariae Cum Uncis 10 parts, Fructus Viticis 12 parts, Ganoderma 9 parts, Radix Polygoni Multiflori 7 parts, Rhizoma Arisaematis 5 parts, Scorpio 6 parts and 9 parts of Radix Glycyrrhizae.
3. the method for the Chinese medicine composition of preparation treatment cerebral thrombosis as claimed in claim 1, it is characterized in that, the parts by weight of the raw material of described Chinese medicine composition are as follows: leaf of Moringa 28 parts, Radix Notoginseng 23 parts, Radix Salviae Miltiorrhizae 20 parts, Rhizoma Chuanxiong 13 parts, Rhizoma Sparganii 13 parts, Radix Curcumae 12 parts, Spica Prunellae 15 parts, Caulis Spatholobi 15 parts, Ramulus Uncariae Cum Uncis 8 parts, Fructus Viticis 6 parts, Ganoderma 7 parts, Radix Polygoni Multiflori 5 parts, Rhizoma Arisaematis 3 parts, Scorpio 3 parts and 5 parts of Radix Glycyrrhizae.
4. the method for the Chinese medicine composition of preparation treatment cerebral thrombosis as claimed in claim 1, it is characterized in that, the parts by weight of the raw material of described Chinese medicine composition are as follows: leaf of Moringa 36 parts, Radix Notoginseng 28 parts, Radix Salviae Miltiorrhizae 25 parts, Rhizoma Chuanxiong 18 parts, Rhizoma Sparganii 17 parts, Radix Curcumae 17 parts, Spica Prunellae 20 parts, Caulis Spatholobi 19 parts, Ramulus Uncariae Cum Uncis 12 parts, Fructus Viticis 14 parts, Ganoderma 11 parts, Radix Polygoni Multiflori 8 parts, Rhizoma Arisaematis 7 parts, Scorpio 9 parts and 13 parts of Radix Glycyrrhizae.
5. the method for the Chinese medicine composition of the preparation treatment cerebral thrombosis as described in claim 1-4 is arbitrary, it is characterised in that: described Chinese medicine composition is made into granule, pill, powder, tablet or capsule.
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Application publication date: 20160803 |